Letterhead Press Releases

Issued – Wednesday, 3 December 2008, Johannesburg, South Africa (SCIENTIFIC)

Major cervical cancer vaccination drive kicks off as GSK announces substantial price decrease in cancer vaccine

A major cervical cancer vaccination drive saw the light of day in Johannesburg today. Championed by renowned investigative journalist Debora Patta, and supported by leading experts such as gynaecologist, Dr Peter Koll, the initiative was given a major boost by leading research-based pharmaceutical and healthcare company GlaxoSmithKline (GSK).

Speaking at the launch of the initiative, David Pritchard, General Manager of GSK South Africa, pledged the unequivocal support of GSK to the cervical cancer drive. He stated that the company was so committed to this cause that it would with immediate effect reduce the cost of its cancer vaccine, Cervarix®, by 36 percent or a cost of R450 per dose (single exit price excluding) VAT.

“This important initiative is in line with GSK’s commitment to fast-track the global accessibility of the cervical cancer vaccine. It is our vision to ensure that South African women across the age spectrum receive every possible protection from this preventable disease. In a developing country such as South Africa affordability is an important issue and with this reduction in cost we will be bringing the cervical cancer vaccine within direct reach of many more South African women. In doing so we hope to work in close partnership with other stakeholders, including Government, to further increase the availability of cervical cancer vaccination through better infrastructure, wider distribution, better disease awareness, education and affordability. We are open to discussing access strategies including pricing with potential partners including Government,” added Pritchard.

Commenting on the vaccination drive and the many barriers to cancer vaccination Debora Patta said: “Like so many other South African1 women and mothers, I never knew that more women develop and die of cervical cancer than any other type of cancer. Given the fact that worldwide a woman dies of cervical cancer every two minutes1 the dangers and impact of cervical cancer is shockingly low. To put this into perspective - each year in South Africa alone, approximately 6 700 women will develop cervical cancer while an estimated 3 700 will die from it.1

Registration No.: 8/030135/07 Address: Flushing Meadows The Campus 57 Sloane Street Bryanston 202, Gauteng cervical cancer vaccination drive…/more

cervical cancer vaccination drive…/two

One in every 261 women in this country face the risk of developing cervical cancer in her lifetime. In my mind that is one too many. Against the background of these facts how can this disease and its active prevention not be top of mind amongst South African women?” asked Patta.

“Without doubt, the development of the vaccine represents a great step forward for women around the world. It is built on Nobel-recognised science and the women who most need it are either totally unaware of its existence or can simply not access it. We live in a time of modern miracles – it is possible to protect ourselves against one of the world’s bigger killers, cervical cancer. As women we owe it to ourselves, and our children to ensure that every young girl is made aware that she can do something to assist in the prevention of cervical cancer. To this end education and accessibility must be substantially improved.”

Formulated with its novel adjuvant ASO4, Cervarix®, offers clear benefits for adolescent and adult women by providing strong and sustained protection against persistent infections and precancerous lesions, the necessary cause for development of cervical cancer. Cervarix® is the only vaccine to date offering high and sustained anti-body levels against HPV 16 & 18 for more than six years. The duration of protection is particularly important as women may acquire infections throughout their lifetime.

Data from clinical trials has indicated that Cervarix® provides 100% efficacy against precancerous lesions (CIN2+) causally related to HPV 16 and 18. These virus types are responsible for 70% of all cervical cancer cases worldwide. In addition, Cervarix® offers cross protection for HPV 31 and 45, the 3rd and 4th most common HPV types.

Adding his voice to that of Debora Patta and David Pritchard, respected Sandton based gynaecologist, Dr Peter Koll said that GSK’s decision to reduce the cost of the vaccine was a major breakthrough in the fight against cervical cancer. “It is one of the major healthcare discoveries of the early 2000’s, and in my opinion is the single biggest advance in medicine in the time that I have been in practice,” said he.

“ As a practicing gynaecologist I can tell you of the devastation and pain and even about the unnecessary loss of life that inevitably accompanies a diagnosis of cervical cancer. Now we can

Registration No.: 8/030135/07 Address: Flushing Meadows The Campus 57 Sloane Street Bryanston 202, Gauteng cervical cancer vaccination drive…/more

cervical cancer vaccination drive…/three at last start chipping away at the numbers of patients that are diagnosed with the disease. For that I applaud the cervical cancer vaccination drive and the generosity of spirit displayed by GSK in dropping the price of Cervarix® by 36%.”

According to Dr Koll protection strategies against cervical cancer should include routine screening together with a vaccine designed to provide long-lasting protection against the most common cancer-causing types. “Vaccination should start as young as possible and in the case of young girls should be viewed as the last of the childhood vaccinations. However, vaccination should be discussed with women of all ages as most women would benefit from the vaccine.”

GSK’s cervical cancer vaccine is a HPV vaccine indicated for the prevention of precancerous cervical lesions associated with the most common cervical cancer-causing HPV types 16 and 18. GSK’s cervical cancer vaccine is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response and increase the duration of protection against cancer-causing virus types.

ENDS Notes to Editors

• About cervical cancer

Worldwide cervical cancer is the second leading cause of cancer in women causing over 270 000 deaths per year.1 It occurs when infection with the human papillomavirus becomes persistent and progresses to cancer.

Up to 80 per cent of sexually active women will acquire a human papillomavirus infection in their lifetime, with the risk of persistence increasing with age.1 Approximately 100 types of human papillomavirus have been identified to date2 and, of these, approximately 15 virus types are considered to cause cervical cancer.3 Virus types 16, 18, 45 and 31 are responsible for approximately 80 percent of cervical cancers globally.2,3

• About GlaxoSmithKline and GlaxoSmithKline Biologicals

In the next five years, GSK expects to launch a number of significant new vaccines to protect against a range of serious diseases.

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media.

Registration No.: 8/030135/07 Address: Flushing Meadows The Campus 57 Sloane Street Bryanston 202, Gauteng GSK Biologicals (GSK Bio), one of the world’s leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline’s activities in

cervical cancer vaccination drive…/more

cervical cancer vaccination drive…/four more cost-effective and convenient combination products to prevent infections that cause the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world – an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination paediatric vaccines that protect the world’s children from up to six diseases in one vaccine.

For more information, please contact: Mandy Keegan, GSK: (011) 745 6352

References

1. Ferlay J et al. GLOBOCAN 2002, IARC 2004. 2. Smith JS, Lindsay L, Hoots B, et al. human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update. Int J Cancer 2007; 121:621-32. 3. Muñoz N, Bosch FX, de Sanjose S, et al. epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348: 518-27.

Released on behalf of GlaxoSmithKline (GSK) by Martina Nicholson Associates (MNA) For further information please contact Martina Nicholson on 011 469 3016 or 083 631 6647; [email protected]

Registration No.: 8/030135/07 Address: Flushing Meadows The Campus 57 Sloane Street Bryanston 202, Gauteng